PET-TC in Thyroid Evaluation (PEPATI-MN-2024)

February 26, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Ruolo Della PET/TC Nella Valutazione di Patologia Tiroidea in un Centro di Medicina Nucleare ad Alto Volume Diagnostico

The thyroid gland may have a diffuse or focal uptake of numerous PET/CT radiopharmaceuticals and this may be correlated with underlying benign and malignant thyroid/parathyroid pathologies.

It is not clear at present if the uptake of the radiopharmaceutical alone is associated with a potential malignancy of the disease.

The aim of the study is to collect evidence and consolidate the diagnostic power of PET/CT, to identify any predictive parameters that can determine whether PET positivity/negativity can in the future avoid unnecessary tests such as needle aspiration.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The primary objective of the study is to measure the diagnostic performance of PET/CT (with tracers used in our Center for Nuclear Medicine by normal clinical practice), in the identification of malignancy of thyroid or parathyroid findings, compared to cytological/histological examination in patients with known thyroid and/or parathyroid disease or in patients with incidental findings. The secondary objective is to find functional parameters and predictive imaging of malignancy/benign and risk class of the lesion.

Study Type

Observational

Enrollment (Estimated)

418

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bo
      • Bologna, Bo, Italy, 38050
        • Nuclear medicine, IRCCS, Azienda Ospedalierio-Universitaria di Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients belonging to the U.O. of Nuclear Medicine IRCCS - University Hospital of Bologna - Polyclinic S. Orsola, who have performed or are to perform PET/CT for thyroid/parathyroid disease or other clinical indication with incidental detection of thyroid/parathyroid disease or patients undergoing PET/CT with known thyroid/parathyroid disease (for example, patients with thyroid nodules already subjected to needle aspiration) as part of the normal care path for a period of 5 years and 6 months.

Description

Inclusion Criteria:

For the retrospective part:

  • Patients aged >18 years,
  • Findings of hypercaptant of thyroid/parathyroid relevance to PET/CT or known thyroid or parathyroid pathology and subsequent execution of PET/CT according to normal clinical practice,
  • Patients with cytological examination derived from needle aspiration performed no more than 12 months time apart from PET/CT.
  • Obtaining informed consent

For the prospective part:

  • Patients aged >18 years,
  • Finding hypercaptant findings of thyroid/parathyroid relevance to PET/CT or known thyroid or parathyroid pathology and subsequent execution of PET/CT according to normal clinical practice.
  • Patients scheduled for agesult to be no more than 12 months.
  • Obtaining informed consent

Exclusion Criteria:

  • Nothing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pepati group
Patients belonging to the U.O. of Nuclear Medicine IRCCS - University Hospital of Bologna - Polyclinic S. Orsola, who have performed or are to perform PET/CT for thyroid/parathyroid disease or other clinical indication with incidental detection of thyroid/parathyroid disease or patients undergoing PET/CT with known thyroid/parathyroid disease (for example, patients with thyroid nodules already subjected to needle aspiration) as part of the normal care path for a period of 5 years and 6 months.
Other: clinical practice drug treatment
Observational, prospective and retrospective study, transversal, non-profit, monocentric. All data of patients affected/ afferents to theU.O. of Nuclear Medicine of the IRCCS AOU of Bologna will be collected submitted/ who will undergo a PET/ CT investigation for thyroid pathology or other indication with incidental feedback of thyroid uptake and patients who have They undergo PET/CT with known thyroid disease. Of these patients will be collected the personal data, clinical news, data related to PET/ CT (dedicated software e.g. MIM), biochemical/ laboratory and anatomopathological (for operated patients), any other imaging investigations already performed and to be performed later by normal clinical practice. The medical nuclear images will be evaluated by at least two nuclear medical experts, with qualitative, semi-quantitative and radiometric parameters as far as possible. Patients will be treated according to normal clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnostic performance
Time Frame: 5 years and 6 months
Sensitivity, specificity, AUC, detection rate, accuracy, positive and negative predictive value compared to the reference standard.
5 years and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2029

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEPATI-MN-2024
  • 322/2024/Oss/AOUBo (Registry Identifier: AOU Bologna)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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